Tonix Pharmaceuticals Reports Positive Phase 1 Data for Lyme Disease Prophylaxis Candidate TNX-4800

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced positive Phase 1 data for TNX-4800, a long-acting monoclonal antibody targeting Borrelia burgdorferi, demonstrating rapid absorption, sustained protective levels for at least four months and a favorable safety profile in healthy subjects. The company said the single-dose subcutaneous therapy could offer a preventative option for Lyme disease, with plans to initiate an adaptive Phase 2 field study in the first half of 2027, pending FDA clearance, to evaluate protection in individuals in endemic areas.

The Phase 1 data indicates TNX-4800 achieved rapid absorption following subcutaneous administration, with serum concentrations reaching levels predicted to be protective against Borrelia burgdorferi, the bacterium that causes Lyme disease. These protective levels were maintained for a minimum of four months after a single dose, suggesting the potential for seasonal or extended prophylaxis. The safety profile was favorable, with no serious adverse events reported, supporting further clinical development. This development is significant as Lyme disease incidence continues to rise in many regions, and current prevention primarily relies on personal protective measures and post-exposure antibiotics, which have limitations.

Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. The company's CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® and Tosymra®. Tonix's product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. The latest news and updates relating to TNXP are available in the company's newsroom at https://ibn.fm/TNXP.

The planned adaptive Phase 2 field study represents a critical next step, aiming to evaluate the real-world efficacy of TNX-4800 in preventing Lyme disease among individuals at high risk in endemic areas. An adaptive design allows for modifications based on interim data, potentially accelerating the development timeline. Success in this trial could address a significant public health need, offering a novel prophylactic strategy. The company's broader immunology pipeline also includes TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection, highlighting its diversified approach to tackling immune-related conditions.

This announcement underscores the ongoing innovation in monoclonal antibody therapies for infectious disease prevention. If successful, TNX-4800 could become the first specifically indicated prophylactic for Lyme disease, providing an important tool for public health efforts in affected regions. The progression into Phase 2 studies, contingent on regulatory feedback, will be closely watched by the medical community and investors alike, as it represents a potential paradigm shift in managing this vector-borne illness. The company's commitment to advancing this candidate reflects the growing recognition of the need for effective preventive measures against Lyme disease, which can lead to serious long-term complications if not treated promptly.